Lead Operations. Drive Innovation. Deliver Life-Changing Therapies.
Are you a results-driven pharmaceutical operations leader with a passion for building high-performing teams, advancing manufacturing excellence, and delivering client success?
We are seeking a Manager, Drug Product Operations & Engineering to lead our Drug Product Operations team and play a critical role in the successful development and manufacture of clinical-stage pharmaceutical products.
This is an exciting opportunity to oversee a broad portfolio of operational, technical, engineering, and commercial activities while partnering with clients and internal stakeholders to bring innovative therapies to patients.
As a key member of the leadership team, you will provide strategic direction for manufacturing operations, engineering initiatives, production planning, warehouse and materials management, and continuous improvement programs. You will also serve as a trusted technical and commercial partner, helping clients achieve their development milestones while ensuring operational excellence, regulatory compliance, and business growth.
What You'll Do:
Operational Leadership
- Lead all Drug Product manufacturing operations supporting client development programs and the production of cGMP clinical supply materials.
- Oversee daily operations within production suites, warehouse activities, materials management, and associated support functions.
- Ensure facilities, equipment, and manufacturing operations remain inspection-ready and compliant with GMP requirements.
- Drive operational excellence through effective production planning, scheduling, resource allocation, and inventory management.
Technical & Engineering Leadership
- Provide strategic leadership to Drug Product Technical and Engineering teams.
- Support client programs through process development, technology transfer, scale-up, and manufacturing activities.
- Serve as the department's primary technical resource for existing and future manufacturing equipment and capabilities.
- Partner with Engineering teams to maintain a robust equipment qualification and preventive maintenance program.
- Identify, evaluate, and implement new technologies, capital projects, and continuous improvement initiatives.
Business & Client Partnership
- Serve as the primary commercial lead for the department.
- Support revenue forecasting and ensure accurate and timely revenue recognition.
- Lead the development of competitive client proposals and quotations.
- Build strong relationships with current and prospective clients, providing technical insight and program updates throughout development projects.
Process Optimization & Continuous Improvement
- Collaborate with Formulation, Analytical, Quality, and other cross-functional teams to develop robust and scalable manufacturing processes.
- Implement process improvements that enhance efficiency, productivity, quality, and cost performance.
- Conduct pre-production batch reviews to ensure operational readiness and safety compliance.
- Troubleshoot facility, equipment, and process issues using sound scientific and engineering principles.
Quality, Compliance & Safety
- Ensure compliance with all applicable GMP, Quality Systems, Environmental, Health & Safety, and regulatory requirements.
- Develop, review, and maintain SOPs and operational procedures as required.
- Provide leadership that fosters a strong culture of safety, quality, accountability, and continuous improvement.
- Interface with regulatory agencies, auditors, inspectors, and external stakeholders as needed.